11.100.20 : Biological evaluation of medical devices

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  • DIN EN ISO 10993-4/A1:2024-04

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024), German and English version EN ISO 10993-4:2017/prA1:2024
    4/1/2024 - PDF - English, German -
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    €59.63

  • DIN EN ISO 7405:2024-04

    Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024), German and English version prEN ISO 7405:2024
    4/1/2024 - PDF - English, German -
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    €163.74

  • DIN EN ISO 10993-17:2024-02

    Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023), German version EN ISO 10993-17:2023
    2/1/2024 - PDF - German -
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    €169.25

  • DIN EN ISO 10993-18:2023-11

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022), German version EN ISO 10993-18:2020 + A1:2023
    11/1/2023 - PDF - German -
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    €179.72

  • DIN EN ISO 10993-15:2023-07

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019), German version EN ISO 10993-15:2023
    7/1/2023 - PDF - German -
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    €92.62

  • DIN EN ISO 10993-10:2023-04

    Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021), German version EN ISO 10993-10:2023
    4/1/2023 - PDF - German -
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    €141.96

  • DIN EN ISO 10993-2:2023-02

    Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022), German version EN ISO 10993-2:2022
    2/1/2023 - PDF - German -
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    €79.72

  • DIN EN ISO 10993-7:2022-09

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019), German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
    9/1/2022 - PDF - German -
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    €184.58

  • DIN EN ISO 20776-2:2022-04

    Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021), German version EN ISO 20776-2:2022
    4/1/2022 - PDF - German -
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    €92.62

  • DIN EN ISO 10993-9:2022-03

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019), German version EN ISO 10993-9:2021
    3/1/2022 - PDF - German -
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    €79.72

  • DIN EN ISO 10993-23:2021-10

    Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021), German version EN ISO 10993-23:2021
    10/1/2021 - PDF - German -
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    €174.39

  • DIN EN ISO 22442-1:2021-08

    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020), German version EN ISO 22442-1:2020.
    8/1/2021 - PDF - German -
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    €115.33

  • DIN EN ISO 10993-12:2021-08

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021), German version EN ISO 10993-12:2021
    8/1/2021 - PDF - German -
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    €99.35

  • DIN EN ISO 10993-1:2021-05

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10), German version EN ISO 10993-1:2020
    5/1/2021 - PDF - German -
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    €131.96

  • DIN EN ISO 14155:2021-05

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020), German version EN ISO 14155:2020
    5/1/2021 - PDF - German -
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    €201.96

  • DIN EN ISO 22442-2:2021-04

    Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020), German version EN ISO 22442-2:2020
    4/1/2021 - PDF - German -
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    €92.62

  • DIN EN ISO 20776-1:2020-12

    Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12), German version EN ISO 20776-1:2020
    12/1/2020 - PDF - German -
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    €85.79

  • DIN EN ISO 7405:2019-03

    Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12), German version EN ISO 7405:2018
    3/1/2019 - PDF - German -
    Learn More
    €126.26

  • DIN EN ISO 10993-11:2018-09

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017), German version EN ISO 10993-11:2018
    9/1/2018 - PDF - German -
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    €120.84

  • DIN EN ISO 10993-11:2018-09

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
    9/1/2018 - PDF - English -
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    €150.93

  • DIN EN ISO 10993-16:2018-02

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
    2/1/2018 - PDF - English -
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    €107.48

  • DIN EN ISO 10993-16:2018-02

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017), German version EN ISO 10993-16:2017
    2/1/2018 - PDF - German -
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    €85.79

  • DIN EN ISO 10993-4:2017-12

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    12/1/2017 - PDF - English -
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    €230.75

  • DIN EN ISO 10993-4:2017-12

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017), German version EN ISO 10993-4:2017
    12/1/2017 - PDF - German -
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    €184.58

  • DIN EN ISO 10993-6:2017-09

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016), German version EN ISO 10993-6:2016
    9/1/2017 - PDF - German -
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    €115.33

  • DIN EN ISO 10993-6:2017-09

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    9/1/2017 - PDF - English -
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    €144.02

  • DIN EN ISO 10993-3:2015-02

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    2/1/2015 - PDF - English -
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    €144.02

  • DIN EN ISO 10993-3:2015-02

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014), German version EN ISO 10993-3:2014
    2/1/2015 - PDF - German -
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    €115.33

  • DIN ISO 13022:2014-06

    Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
    6/1/2014 - PDF - English -
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    €170.93

  • DIN ISO 13022:2014-06

    Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
    6/1/2014 - PDF - German -
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    €136.82

  • DIN EN ISO 10993-13:2010-11

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010), German version EN ISO 10993-13:2010
    11/1/2010 - PDF - German -
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    €85.79

  • DIN EN ISO 10993-13:2010-11

    Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    11/1/2010 - PDF - English -
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    €107.48

  • DIN EN ISO 10993-5:2009-10

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009), German version EN ISO 10993-5:2009
    10/1/2009 - PDF - German -
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    €115.33

  • DIN EN ISO 10993-5:2009-10

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    10/1/2009 - PDF - English -
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    €144.02

  • DIN EN ISO 10993-14:2009-08

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001), German version EN ISO 10993-14:2009.
    8/1/2009 - PDF - German -
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    €79.72

  • DIN EN ISO 10993-14:2009-08

    Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
    8/1/2009 - PDF - English -
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    €99.44

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